510(k) K010114

ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) by Johnson & Johnson Vision Care, Inc. — Product Code LPL

K010114 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Vision Care, Inc. for the device "ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)". The FDA issued a decision of Substantially Equivalent on April 11, 2001. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Johnson & Johnson Vision Care, Inc. has at least 10 other 510(k) clearances on record.